基于蛋白质的RSV预防F孕产妇疫苗 - 过早分娩和其他结果
Ilse Dieussaert1, Joon Hyung Kim1, Sabine Luik1
1From GSK, Wavre, Belgium (I.D., J.-U.S.); GSK, Rockville, MD (J.H.K., W.P.); GSK, Munich, Germany (S.L., C.S.); the Department of Obstetrics and Gynecology, Duke University School of Medicine, Durham, NC (G.K.S.); and GSK, Waltham, MA (P.W., P.R.D.).
The New England journal of medicine
|March 13, 2024
概括
母亲用RSVPreF3-Mat接种的疫苗显示,婴儿的呼吸道同胞病毒 (RSV) 下呼吸道疾病减少. 然而,由于疫苗组中早产风险较高,该试验被提前停止.
科学领域:
- 免疫学 免疫学 免疫学
- 疫苗学 疫苗学 疫苗学
- 儿科 儿科 儿科
背景情况:
- 呼吸道同胞病毒 (RSV) 对婴儿构成重大威胁,需要采取保护策略.
- 怀孕期间对母亲进行疫苗接种是一种潜在的方法,可以为新生儿提供针对RSV疾病的被动免疫.
- 需要对候选RSV预注射F蛋白基孕产妇疫苗 (RSVPreF3-Mat) 的有效性和安全性数据.
研究的目的:
- 评估RSVPreF3-Mat疫苗在孕妇及其婴儿中的有效性和安全性.
- 评估RSV相关的下呼吸道疾病的发病率和12个月龄以下婴儿的安全结果.
主要方法:
- 进行了一项第三期随机化,安慰剂对照试验,涉及18至49岁的孕妇.
- 参与者在怀孕24至34周之间接受RSVPreF3-Mat或安慰剂.
- 由于观察到与早产有关的安全问题,入学被提前停止.
主要成果:
- 针对任何医学评估的RSV相关的下呼吸道疾病,疫苗的疗效为65.5% (95% CI,37.5至82.0).
- 对医学评估的严重RSV相关下呼吸道疾病的疗效为69.0% (95% CI,33.0至87.6).
- 疫苗组 (6.8%) 与安慰剂组 (4.9%) 相比,观察到早产风险更高,P=0.01.
结论:
- RSVPreF3-Mat疫苗在减少RSV相关的婴儿下呼吸道疾病方面表现出有效性.
- 确定了一个重要的安全问题:在接种RSVPreF3-Mat.疫苗的母亲产生的婴儿中,早产风险增加.
- 在可以考虑广泛的母体RSV疫苗接种之前,需要进一步调查安全性,特别是关于早产的情况.
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